Qlaris Phase 2 Study of QLS-111 in POAG and/or OHT Patients

RECRUITING

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Qlaris' Phase 2 clinical trial investigating the safety, tolerability, and ocular hypotensive efficacy of QLS-111 in primary open-angle glaucoma (POAG) or ocular hypertension patients.

Conditions:

🦠 Primary Open Angle Glaucoma (POAG) 🦠 Primary Open Angle Glaucoma of Both Eyes 🦠 Primary Open-Angle Glaucoma, Unspecified Eye 🦠 Ocular Hypertension (OHT)

🗓️ Study Start (Actual) 15 March 2024

🗓️ Primary Completion (Estimated) 5 September 2024

✅ Study Completion (Estimated) 5 September 2024

👥 Enrollment (Estimated) 60

🔬 Study Type INTERVENTIONAL

📊 Phase PHASE2

Locations:

📍 Roswell, Georgia, United States

📋 Eligibility Criteria

Description

Inclusion Criteria:

* 18 years or older
* Able to provide written acknowledgement of giving informed consent
* Best corrected visual acuity (BCVA) 20/200 or better Bilateral POAG or OHT with documented historic IOP value(s) ≥24 mmHg, in either eye
* Post-washout IOP ≥22 mmHg in morning on Visits 2 and 3 and ≥18 mmHg at noon on Visit 2

Exclusion Criteria:

* IOP \>34 mmHg
* Severe glaucomatous damage that would preclude safe washout of prescribed ocular hypotensive medications
* Previous glaucoma surgery, certain procedures (trabeculotomy, shunt/tubes, cyclodestructive procedure) (selective laser trabeculoplasty (SLT) allowed if done no earlier than 1 year from study, some minimally invasive glaucoma surgeries are allowed if done no earlier than 1 year from study)
* Ocular trauma, ocular infections, ocular inflammation, herpes simplex keratitis of eye
* Use of other ophthalmic concomitant medications during the study
* Uncontrolled hypertension or hypotension
* Significant systemic or psychiatric disease
* Participation in other investigational trial 30 days prior to screening or previous enrollment and treatment with Qlaris investigational product
* Pregnant or lactating

Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)

Sexes Eligible for Study: ALL

Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted 18 August 2023
First Submitted that Met QC Criteria 29 August 2023
First Posted 30 August 2023

Study Record Updates

Last Update Submitted that Met QC Criteria 16 March 2024
Last Update Posted 19 March 2024
Last Verified August 2023